NCT01660763

Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

P3 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil NanoTab PCA System/15 mcg	15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.
DRUG	Placebo Sufentanil NanoTab PCA System	Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-08-09
• Last updated: 2015-10-20
• Results posted: 2014-02-03

Locations

1 site across 1 country: United States